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Dermal micro organs, methods and apparatuses for producing and using the same

a microorgan and skin technology, applied in the field of tissue-based microorgans and therapeutic tissue-based microorgans, can solve the problems of limited method of delivery, superficial wounds on patients, and limitations on the size of molecules that can be utilized, and achieve the effect of high production and secretion level and skill

Inactive Publication Date: 2008-12-23
MEDGENICS MEDICAL ISRAEL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

"The present invention provides a DMO / DTMO that can be maintained in a viable state for manipulation while keeping a high production and secretion level of the desired therapeutic agent. The DMO / DTMO can be harvested and implanted without forming keratin cysts or keratin microcysts. The DMO / DTMO can also produce micro keratin cysts that will atrophy within a short period of time. The invention also provides a method and apparatus for harvesting and supporting a skin-related tissue structure to maintain its shape and position. The genetically modified dermal micro organ can also produce recombinant gene products or proteins of interest. The invention also provides a method of delivering the recombinant gene product or protein to a recipient."

Problems solved by technology

In each of these cases the method of delivery is limited by the body processes that the agent is subjected to, by the requirement for frequent administration, and limitations on the size of molecules that can be utilized.
Harvesting of a skin sample leaves a superficial wound on the patient that may last several weeks and may leave scars.
Furthermore, the resulting harvested dermis is generally not uniform in dimensions and includes “plugs” of epidermis at either end of the dermal core.

Method used

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  • Dermal micro organs, methods and apparatuses for producing and using the same
  • Dermal micro organs, methods and apparatuses for producing and using the same
  • Dermal micro organs, methods and apparatuses for producing and using the same

Examples

Experimental program
Comparison scheme
Effect test

example 1

In Vitro Secretion Levels of Human Erythropoietin by DTMO-hEPO

[0206]Experiments were conducted to assay the variability of in vitro hEPO secretion level between DTMOs-hEPO obtained from different human skin samples.

Experimental Procedure

[0207]DTMO-hEPO was prepared (in triplicates) from skin samples obtained from six different human subjects and hEPO secretion levels were measured at various point in time, as indicated in FIG. 4, after the viral vector was washed.

Experimental Results

[0208]The DTMO-hEPO secretion levels were similar among the different human skin samples. In addition, the DTMO-HEPO secretion levels were similar to the secretion levels of hEPO previously obtained from split thickness TMO-hEPO (data not shown).

example 2

Histology

[0209]In order to verify that the DTMO contains mainly dermal components, a histological analysis was performed. MOs were prepared from either split thickness skin or dermal skin samples and histological analysis was performed by a dermato-pathologist. As can be seen on the left side of FIG. 5, the DTMO contains dermal layers and dermal components without residual basal and / or epidermal layers. In comparison, the split thickness TMO, shown on right side of FIG. 5, contains all the skin layers including the basal and epidermal layers.

example 3

Immunocytochemistry Studies

[0210]To study which cells are transduced in the DTMO-hEPO tissue, a histological immunohistochemistry analysis of DTMO-hEPO was performed on day 9 post-harvesting, using an anti-hEPO monoclonal antibody (1:20 dilution). Analysis revealed strong staining of dermal fibroblasts, as shown in FIG. 6. The staining was spread throughout the entire DTMO.

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Abstract

Embodiments of the present invention provide Dermal Micro Organs (DMOs), methods and apparatuses for producing the same. Some embodiments of the invention provide a DMO including a plurality of dermal components, which substantially retain the micro-architecture and three dimensional structure of the dermal tissue from which they are derived, having dimensions selected so as to allow passive diffusion of adequate nutrients and gases to cells of the DMO and diffusion of cellular waste out of the cells so as to minimize cellular toxicity and concomitant death due to insufficient nutrition and accumulation of waste in the DMO. Some embodiments of the invention provide methods and apparatuses for harvesting the DMO. An apparatus for harvesting the DMO may include, according to some exemplary embodiments, a support configuration to support a skin-related tissue structure from which the DMO is to be harvested, and a cutting tool able to separate the DMO from the skin-related tissue structure. Other embodiments are described and claimed.

Description

CROSS REFERNCE DATA[0001]This application claims priority from U.S. Provisional Application No. 60 / 466,793, filed May 1, 2003, and U.S. Provisional Application No. 60 / 492,754, filed Aug. 6, 2003; and is a Continuation in Part of PCT International Applications Nos. PCT / IL02 / 00877, PCT / IL02 / 00878, PCT / IL02 / 00879 and PCT / IL02 / 00880 all filed Nov. 5, 2002, which claims priority of U.S. Provisional Applications Nos. 60 / 330,959, filed Nov. 5, 2001, 60 / 393,745, filed Jul. 8, 2002 and 60 / 393,746, filed Jul. 8, 2002, the disclosures of all of which are incorporated herein by reference in their entirety.FIELD OF THE INVENTION[0002]The invention relates to the field of tissue based micro organs, therapeutic tissue based micro organs and methods and apparatuses for harvesting, processing, implanting and manipulating dermal tissue.BACKGROUND OF THE INVENTION[0003]Various methods for delivering therapeutic agents are known. For example, therapeutic agents can be delivered orally, transdermally, b...

Claims

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Application Information

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Patent Type & Authority Patents(United States)
IPC IPC(8): A01N1/00A61F2/10C12N5/00A01N63/00A01N65/00A61B10/02A61B17/28A61K48/00C12MC12N5/02
CPCA61K38/28C12N5/0698A61F2/105A61K35/36A61K38/193A61K38/2066A61K38/215A61K38/27A61B10/0275C12N2502/094C12N2502/1323C12N2510/00A61B17/322A61B2017/0023A61B2017/00969A61B2017/320052A61B2017/320064A61B2017/3225A61K38/1816A61B2017/2808Y10T83/929A61P17/00A61B17/32053A61B2217/005
Inventor BELLOMO, STEPHEN F.LIPPIN, ITZHAKPIVA, GUILLERMO ALBERTOROSENBERG, LIORBUKHMAN, MORDECHAYSTERN, BARUCH S.SHALHEVET, DAVIDSHAVITT, MENACHEM D.PEARLMAN, ANDREW L.SHANI, NOAMALMON, EINAT
Owner MEDGENICS MEDICAL ISRAEL
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